As per U.S. Food and Drug Administration (FDA) rules, anyone planning to manufacture or distribute a medical device within the United States must either obtain premarket approval (PMA) or complete a 510(k) submission for that device. Either way, the specific type of approval required is wholly dependent on the device’s classification, which is directly correlated with its overall risk value. This value is determined by the risk the device in question can pose to a patient or consumer and is separated into three specific classes: Class I, Class II, and Class III. Each class is organized by severity, with I consisting of low risk devices and III consisting of high-risk devices.
Consequently, medical device manufacturers must adhere to three primary steps. First, they must assess the product in order to determine classifications as per FDA guidelines. Once the product is properly classified, the manufacturer will then determine whether the device requires PMA or a 510(k) submission (more on that in a moment). Finally, the manufacturer must submit the appropriate documentation to the FDA for final approval.
Unfortunately, many manufacturers run into snags when it comes to selecting a 510(k) or PMA. This is a crucial decision because it will have a fundamental impact on any lawsuits that may arise. To help demystify any confusion, here is a description of each, as well as an explanation of how each will affect any impending lawsuits.
An Explanation Of Premarket Requirements
Medical devices are divided into three specific classes due to their determined risk factors (sometimes referred to as a “risk profile”) and intended use. The FDA’s website uses the example of a scalpel to establish a definition of “intended use”. According to them, a scalpel’s intended use is to cut organic tissue. If a more specific use is intended, that designation must be appended to the product’s outer label.
Class I devices pose minimal risks to users and are subject to general medical device regulations. As such, they do not require premarket submissions. Class II devices contain some level of risk and cannot be marketed until a 510(k) has been submitted. A 510(k) is essentially a premarket notification. Items that fall into this category are defined as crucial to healthcare but could cause a critical injury upon malfunctioning. Class II devices include sutures, intravenous kits, pregnancy kits, and motorized wheelchairs.
Finally, Class III devices can be defined as those that sustain life or are surgically implanted. Examples include pacemakers and blood vessel stents. The FDA views these devices as substantially risky to patients’ health. Consequently, these devices require PMA submission before being approved for marketing in the United States.
The Differences Between 510(k) And PMA Approval Processes
We have already outlined one clear distinction between 501(k) approval and PMA processes: Class II medical devices require the former, while Class III requires the latter. However, there are a few other distinctions that must be grasped in order to understand how both affect potential lawsuits.
510(k) submissions give the FDA documentation that establishes substantial equivalence. In other words, it proves your device is equivalent to a preceding device that has already been approved for marketing. These types of submissions usually take anywhere from 30 to 90 days. Establishing substantial equivalence requires one to compare their product with something previously released. Typically, this is done in a laboratory setting and human testing is rarely required. Additional information that will help manufacturers successfully submit a 510(k) include documented design controls process, which encapsulates intended use, as well as design inputs and verification.
PMAs, on the other hand, are decidedly more comprehensive than a 510(k). Essentially, they are used to prove that a device is both safe and effective for potential users. This usually necessitates laboratory testing as well as clinical trials involving humans. Needless to say, PMAs have much higher standards than their counterparts. Additionally, the FDA has up to 180 days to accept or reject the application, so the procedure is considerably more stringent.
As far as 510(k)’s are concerned, it is up to the plaintiff and defense attorneys to assess relevant evidence as it relates to the case at hand. This assessment can be conducted during any phase of the trial, including prior to filing a complaint, during pretrial, and during discovery. Historically, most defense attorneys prefer to present 510(k) compliance information directly to a jury. The submission of the 510(k) itself shows that their clients adhered to regulations as well as exercised proper safety precautions prior to bringing their medical device to market.
The goal of the defense is to get the jury to agree that the FDA’s approval of the 510(k) meets the societal safety standards in such a way that shows the manufacturer maintained the utmost responsibility and genuine concern for public safety. Plaintiffs, on the other hand, typically do not want 510(k) evidence to go before a jury at all. Their lawyers will usually argue that the substantially equivalent standard of the 510(k) does not correlate with societal safety standards. This stands in stark contrast with PMA standards, as they usually meet these requirements by design. Plaintiffs typically make this argument knowing full well that the jury may decide in the defendant’s favor because the medical device has already passed FDA standards (obviously without knowing that they are far less stringent than what is required for a PMA).
A foundational decision was reached in 1996, when the United States Supreme Court weighed in on Medtronic, Inc. v. Lohr, 518 U.S. 470, which directly concerned the FDA’s approval processes for PMA and 510(k). They found that the FDA averaged approximately 20 hours on each 510(k), while spending an average of 1,200 hours on each PMA. This allowed the court to reach the conclusion that the PMA process is much more thorough and stringent than the 510(k). Today, this decision is integral to current court battles centered around the 510(k).
The 510(k) process is frequently criticized for what is perceived to be a lack of scrutiny, especially when contrasted with the PMA process. More specifically, opponents argue that the substantially equivalent test is not thorough enough to protect consumers in the first place. A frequent weapon used by opponents is statistics addressing the recall rates of 510(k) Class I medical devices. Another popular argument is that the FDA is not privy to all of the information in the manufacturer’s possession or does not have enough employees to exercise proper oversight.
On the other side of things, proponents of the 510(k) argue that the process strikes a perfect balance between safety and availability. In their view, eligible devices receive attention that is equivalent to any potential dangers. Much like the opponents, proponents have their own set of statistical data they love to cite. One study argues that a mere 0.2 percent of all 510(k) approved devices experienced a Class I recall. Further, they argue that the substantially equivalent standard is proof that the FDA has declared the medical device safe for public use.
Staying on top of these dynamically evolving arguments is essential for future prosecution and defense strategies. Additionally, the opposing viewpoints will help define new standards during litigation.